Coloplast recalls Titan NB Scrotal Zero Ang 18cm inflatable penile prostheses (EN88182400) due to potential premature pump failure from decreased wall thickness. Affected units have specific catalog and lot numbers.
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Coloplast is recalling certain Titan NB Scrotal Zero Ang 18cm inflatable penile prostheses because the pump may fail prematurely due to reduced wall thickness. This could lead to the device not functioning properly during use.
The pump in these prostheses has thinner walls than standard, which may cause it to fail earlier when inflating and deflating the device. This could result in the prosthesis not working as intended during use.
Men who own or use the recalled Titan NB Scrotal Zero Ang 18cm inflatable penile prosthesis with catalog number EN88182400 and lot numbers 8887622 or 8965351 are affected. Those with medical implants requiring this device are at higher risk.
Check for the catalog number EN88182400 on the product label. Lot numbers 8887622 or 8965351 are also associated with this recall.
Verify the catalog number EN88182400 and lot numbers 8887622 or 8965351 on the device label.
The recalled product is the Titan NB Scrotal Zero Ang 18cm inflatable penile prosthesis with catalog number EN88182400.
Lot numbers 8887622 and 8965351 are affected by this recall.
The recall record does not specify any remedy.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1366-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1366-2023 from Coloplast. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
